NCT03759301

Brief Summary

The objective of this study is to assess the effectiveness of adjuvant growth hormone injection during controlled ovarian stimulation, in poor responder women undergoing intracytoplasmic sperm injection (ICSI) procedures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

December 20, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2019

Completed
Last Updated

June 24, 2019

Status Verified

June 1, 2019

Enrollment Period

5 months

First QC Date

November 22, 2018

Last Update Submit

June 21, 2019

Conditions

Infertility, Female

Keywords

Growth HormoneIVF/ICSIPoor Responders

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    The main outcome is clinical pregnancy per allocated woman, defined as the presence of at least one fetus with heart beat.

    3 weeks

Secondary Outcomes (5)

  • E2 levels

    Day 1 of COS, the same day of Human Chorionic Gonadotropin (HCG) injection

  • Number of oocytes collected

    Day 6 of COS

  • Metaphase I (MI) and Metaphase II (MII) oocyte number

    Day 6 of COS

  • Number of Pronucleus

    Day 6 of COS

  • Multiple pregnancy

    6 weeks from last period

Study Arms (2)

Growth Hormones Somatropin Recombinant

ACTIVE COMPARATOR

Growth hormone (Somatropin) 4 IU/day subcutaneous from the 2nd day of the cycle and stopped 1 day before ovum pickup for the treatment group which consists of 70 women.

Drug: Growth Hormones Somatropin Recombinant

Placebo saline solution

PLACEBO COMPARATOR

Control group consisting of 70 women who will receive subcutaneous placebo injection in the same dosing as the treatment group

Drug: Placebo saline solution

Interventions

Growth Hormones Somatropin RecombinantDRUG

Growth Hormones Somatropin Recombinant 4 IU/day subcutaneous from the 2nd day of the cycle and stopped 1 day before ovum pickup

Also known as: Cetrorelix
Growth Hormones Somatropin Recombinant
Placebo saline solutionDRUG

same volume as growth hormone ampule used

Also known as: Cetrorelix
Placebo saline solution

Eligibility Criteria

Age25 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 25 to 38 years old.
  • IVF previous poor responders: at least two failed cycles with \< five oocytes or abnormal ORT e.g. antimullerian hormone \< 1
  • Patients with unexplained infertility.
  • Normal follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin and ovarian ultrasound.
  • Normal pelvic ultrasound including 3D ultrasound of the uterus with no detected hydrosalpinx.

You may not qualify if:

  • Refusal to participate in the study
  • Patients with known medical disease (e.g. severe hypertension or hepatic disease).
  • Altered karyotype in one or both partners.
  • History of chronic, autoimmune or metabolic diseases
  • Presence of endocrinopathies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Azhar University Hospitals (Kasr Al-Aini)

Cairo, Egypt

Location

Related Publications (2)

  • Sood A, Mohiyiddeen G, Ahmad G, Fitzgerald C, Watson A, Mohiyiddeen L. Growth hormone for in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD000099. doi: 10.1002/14651858.CD000099.pub4.

    PMID: 34808697DERIVED

  • Mohammad EH, Abou El Serour AG, Mohamed EAH, Abbasy AH, Zaatar M, Rageh KA, Shafeek MM, Issak ER. Efficacy of growth hormone supplementation with ultrashort GnRH antagonist in IVF/ICSI for poor responders; randomized controlled trial. Taiwan J Obstet Gynecol. 2021 Jan;60(1):51-55. doi: 10.1016/j.tjog.2020.10.003.

    PMID: 33495008DERIVED

MeSH Terms

Conditions

Infertility, Female

Interventions

Growth Hormonecetrorelix

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Mohamed M Shafeek, MSc

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 22, 2018

First Posted

November 29, 2018

Study Start

December 20, 2018

Primary Completion

May 5, 2019

Study Completion

June 5, 2019

Last Updated

June 24, 2019

Record last verified: 2019-06

Locations

EG(1)